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Preventive correction of fibrinolysis with Epsilon Aminocaproic Acid detected by Thromboelastometry during Liver Transplant

Prophylactic correction of fibrinolysis with Epsilon Aminocaproic Acid diagnosed by Thromboelastometry during Orthotopic liver transplantation

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-105p888f
Enrollment
Unknown
Registered
2023-05-12
Start date
2014-05-01
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Liver transplantation

Interventions

Patients were randomized into 2 groups. 24 patients received aminocaproic acid (20 mg/kg/h), in a total of 500ml containing 10 grams of aminocaproic acid, in a continuous intravenous infusion pump, in

Sponsors

José Carlos Rodrigues Nascimento
Lead Sponsor
José Carlos Rodrigues Nascimento
Collaborator

Eligibility

Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Patients undergoing liver transplantation; both sexes; age from 18 years

Exclusion criteria

Exclusion criteria: Patients with contraindications to antifibrinolytic therapy; such as disseminated intravascular coagulation; bacteremia; portal thrombosis; Budd-Chiari syndrome; neoplasia; autoimmune hepatitis; acute or chronic renal failure; those who refused to participate in the study

Design outcomes

Primary

MeasureTime frame
It is expected to find a difference between the means of at least 5% of maximum lysis in the anhepatic phase between the intervention and control groups, verified using the Two-way ANOVA method and Bonferroni posttests.;Using Two-way ANOVA and Bonferroni posttests, we observed a 15% reduction in mean hyperfibrinolysis in the group of patients treated with epsilon aminocaproic acid (P<0.001) when compared to those in the control group during the anhepatic phase.

Secondary

MeasureTime frame
The other EXTEM and FIBTEM analyses are expected to show a difference of at least 5%, verified using the Two-way ANOVA method and Bonferroni posttests. ;We did not find a significant difference in the other EXTEM or FIBTEM analyses using the Two-way ANOVA method or Bonferroni posttests. ;It is expected to find a difference between the proportions or means of transfusion of blood products and/or the administration of hemostatic products of at least 5%, using the Fisher's or Mann-Whitney method. As well as the percentage of patients who received a transfusion of blood products and/or hemostatic products, both intraoperatively and within 24 hours postoperatively, verified using the Two-way ANOVA method and Bonferroni posttests.;Using the Fisher's or Mann-Whitney method, regarding the mean transfusion of blood products and/or administration of hemostatic products, there was no significant difference between the two groups, both intraoperatively and within 24 hours postoperatively . Also, in the analysis of the percentage of patients who received transfusion of blood products and/or hemostatic products, there was no significant difference between the two groups, both intraoperatively and within 24 hours postoperatively.;It is expected to find a difference of at least 5% between the proportions or means of postoperative complications such as pulmonary infection, acute rejection, hepatic artery thrombosis, sepsis, reoperation within 24 hours of the postoperative period and acute renal failure between groups, verified using the Fisher's or Mann-Whitney method.;Using the Fisher's or Mann-Whitney method, we did not observe any statistical difference related to postoperative complications, such as pulmonary infection, acute rejection, hepatic artery thrombosis, sepsis, reoperation within 24 hours of the postoperative period and acute renal failure in both groups.;Identify any difference between the proportions or means of patients who were discharged from hospital and those

Countries

Brazil

Contacts

Public ContactJosé Nascimento

Hospital Geral de Fortaleza

jcr.nascimento@hotmail.com55(85)996688500

Outcome results

None listed

Source: REBEC (via WHO ICTRP)